Mission Statement

As part of the federal government’s National Institutes of Health (NIH), the National Eye Institute’s mission is to “conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind.”

SUMMARY
The “3-D Retina Organoid'' Challenge (the “Challenge''), is an ideation Challenge in which the National Eye Institute (NEI; http://www.nei.nih.gov/), part of the National Institutes of Health (http://www.nih.gov), is asking for ideas to maximize the physiological relevance of 3-D human retina culture systems. Currently, retina culture models do not capture the complexity of the human retina. The goal of the Challenge is to transform innovative ideas into concrete concepts to develop new in vitro 3-D human retina models that recapitulate the organization and function of the human retina. NEI intends to follow this challenge with a follow-on but distinct Reduction to Practice Challenge, which will aim to invoke scientific and technological development of the model system. Technological breakthroughs in this arena could allow researchers and physicians to better understand, diagnose, and treat retinal diseases.

DATES AND DEADLINES

Solutions must be submitted to challenge.gov by NOON Eastern time on August 1, 2017.

THE IC'S STATUTORY AUTHORITY TO CONDUCT THE CHALLENGE
The general purpose of the NEI is to conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind. The NEI is also conducting this challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, 15 U.S.C. 3719. In line with these authorities, this Challenge will lead to innovative ideas for developing technology to accelerates vision research, generate new models for retinal diseases, and facilitate translation of basic research into better treatments.

SUBJECT OF THE CHALLENGE COMPETITION
Around the world, an estimated 285 million people are visually impaired; of these, 39 million are blind. In many cases, blindness and vision loss are the result of retina-damaging diseases that, if better understood, could be treated or have interventions applied to stop degeneration or provide protection to remaining viable cells. One limitation in furthering research in this area is that eye tissue to study disease processes is not readily available. However, retina biology researchers have developed methods to grow 3-D retina models in vitro from induced pluripotent stem cells (iPSC) and embryonic stem cells (ESC). Current protocols vary in their strengths and limitations, but none can robustly recapitulate the complexity and functionality of the retina. In this Challenge, NEI seeks concept solutions outlining methods and protocols to develop a 3-D human retina organoid prototype that is physiologically relevant. Protocols to develop such a model system could be transformational for vision research and regenerative medicine. New models could be used for applications such as understanding eye development, studying retinal biology, modeling diseases, identifying and testing treatments, and serving as a tissue source to use in transplantation. In this Challenge, the protocols to make models used for disease modeling and drug testing are desired, and solution(s) should yield protocols that allow reproducible culture of functionally-competent retina organoids. This Challenge will speed up the efforts toward this goal.

RULES FOR PARTICIPATING IN THE CHALLENGE
Solvers must be 18 years of age or older and may participate singly or as part of one or more teams. Teams are not limited in the number of members. Each team must designate a captain who must be a U.S. citizen or permanent resident who is responsible for all correspondence regarding this Challenge. Teams may also merge, collaborate, subdivide, or otherwise organize themselves and their members as needed to prepare a solution for this challenge.

The Challenge has a special solver category exclusively for trainees (e.g., students, postdoctoral fellows, medical students). To be eligible to submit solutions to this category, solvers must show documentation that they are currently pursuing a degree or, in the case of post-docs, show proof of their position. A trainee competing in this category can do so as an individual or as part of a team of trainees and may submit one or more proposals. If a trainee competes in this category on a trainee team and also competes as a member of a non-trainee team, she/he must submit a letter from his/her advisor stating that the solution submitted by the trainee team is composed of the trainee’s own, independent, ideas. NEI will evaluate solutions to the trainee category separately, and the category will have separate prizes.

To be eligible to win a prize under this challenge, an individual or entity—

Shall have registered to participate in the Challenge under the rules promulgated by the NIH as published in this Notice;

Shall have complied with all the requirements set forth in this Notice;

In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. However, non-U.S. citizens and non-permanent residents can participate as a member of a team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced.

May not be a Federal entity or federal employee acting within the scope of their employment;

May not be an employee of HHS (or any component of HHS) acting in their personal capacity;

Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency Ethics Official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this challenge;

May not be a judge of the challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).

Federal grantees may not use Federal funds to develop their Submissions.

Federal contractors may not use Federal funds from a contract to develop their Submissions or to fund efforts in support of their Submission.

Submissions must not infringe upon any copyright or any other rights of any third party.

By participating in this Challenge, each individual (whether competing singly or in a group) and entity agrees to assume any and all risks and waive claims against the Federal government and its related entities (as defined in the COMPETES Act), except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.

Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no individual (whether competing singly or in a group) or entity participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.

By participating in this Challenge, each individual (whether competing singly or in a group) and entity agrees to indemnify the Federal government against third party claims for damages arising from or related to Challenge activities.

An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during the Challenge if the facilities and employees are made available to all individuals and entities participating in the Challenge on an equitable basis.

By participating in this Challenge, each individual (whether participating singly or in a group) and each entity grants to the NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly the Submission on the web or elsewhere. Each participant will retain all other intellectual property rights in their Submissions, as applicable.

NIH reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, and/or (b) not award any prizes if no entries are deemed worthy.

Each individual (whether participating singly or in a group) or entity agrees to follow all applicable federal, state, and local laws, regulations, and policies.

By participating in this Challenge, each individual (whether participating singly or in a group) warrants that he or she is the sole author or owner of, or has the right to use, any copyrightable works that the Submission comprises, that the works are wholly original with the Solver (or is an improved version of an existing work that the Solver has sufficient rights to use and improve), and that the Submission does not infringe any copyright or any other rights of any third party of which Solver is aware. To receive an award, Solvers will not be required to transfer their intellectual property rights to NEI, but Solvers must grant to the federal government a nonexclusive license to practice their solutions and use the materials that describe them. This license must grant to the United States government a nonexclusive, nontransferable, irrevocable, paid-up, royalty-free license to practice or have practiced for or on behalf of the United States throughout the world any invention made by the Solvers that covers the Submission. In addition, the license must grant to the federal government and others acting on its behalf, a fully paid, nonexclusive, irrevocable, worldwide license in any copyrightable works that the Submission comprises, including the right to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly said copyrightable works. To participate in the Challenge, each Solver must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of Solver's rights to the federal government.

Each individual (whether participating singly or in a group) and entity participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such participant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.

By participating in this Challenge, each individual (whether participating singly or in a group) agrees to all NEI to publicly display (e.g., on web sites) solution abstracts.

REGISTRATION PROCESS FOR PARTICIPANTS
Solvers may access the registration and submission platform by visiting challenge.gov and searching for “NEI 3-D Retina Organoid Challenge.” Every solver must register for the Challenge, even if participating as a member of a team.

THE PRIZEAmount of the Prize; Award Approving Official. The total prize purse is up to $100,000. Up to $90,000 will be awarded to no more than three prizes for non-trainee solutions. Up to $10,000 will be awarded for no more than three trainee prizes. The NIH reserves the right to cancel, suspend, and/or modify this Challenge at any time through amendment to this notice. In addition, the NIH reserves the right to not award any prizes if no solutions are deemed worthy. The Award Approving Official will be Paul A. Sieving, M.D., Ph.D., Director of the National Eye Institute.Payment of the Prize. Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to Federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.

EVALUATION AND WINNER SELECTIONBasis upon Which Winner Will Be Selected. A panel of non-federal technical reviewers with expertise directly relevant to the Challenge will evaluate the solutions based on feasibility and ability to achieve the following criteria. The solutions and evaluation statements from the technical panel will then be reviewed by federal employees serving as judges, who will select the Challenge winners. The NEI will send feedback from the technical experts and judges to the non-winners.

NEI will apply the same evaluation criteria for trainee and non-trainee Submissions. The percentages assigned to each set of evaluation criteria are guidelines from NEI to suggest which scientific milestones are of emphasis and interest to the institute. All solvers are encouraged to participate in a future Reduction to Practice Challenge that NEI is planning.

Only complete applications will be reviewed.

SUBMISSION REQUIREMENTS AND TEMPLATE

Instructions for submission: Please format proposal using the Application Template and submit to challenge.gov as a word document or PDF. Detailed instructions on the submission process can be found in the application template.

Basis Upon Which Submissions Will Be Evaluated. NEI is seeking innovative solutions to achieve significant advances over currently available protocols to grow retina organoids. As solvers address the evaluation criteria outlined below, they should state how and why they expect their proposed new methods or changes/additions to existing methods will improve aspects of retina organoids. Solutions must outline ideas to produce 3-D retina organoids that:

Are generated from human cells (derived from iPSC, federally approved ESC, multipotent cells, or adult cells subjected to a combination of transdifferentiation/reprogramming methods);

Are physiologically and morphologically relevant to normal or disease state; and

Consist of the major retina cell types and represent their biological functions and interplay.

Solutions that propose to grow cells in 2-D culture using a tissue-on-a-chip system are not of interest for this Challenge. However, creative approaches that incorporate use of microfluidics or perfusion to enhance culture of 3-D organoids are encouraged.

Cell Types: What aspects of protocol ensure that all five neuronal retina cell types (photoreceptors, bipolar cells, ganglion cells, horizontal cells, and amacrine cells) will be produced on included? Will other cell types be generated or included? If the method eliminates a cell type, justify why it is not included (i.e. the disease being modelled lacks the specific cell type).

Structure: What approach (e.g., self-organization or bioengineering with scaffolds, bioprinting, and/or a microfluidic apparatus) is proposed to achieve 3-D assembly? What aspects of the protocol ensure that 3-D organoids will be properly oriented and have layers recapitulating a laminated retina?

Viability: Does the protocol incorporate new procedural steps or technologies that aim to increase duration of viability as compared to current protocols?

Functional characterization of cell types: Does the solution incorporate novel steps or technologies that may enable all cell types to remain functional through the latest viable time point?